Trial Outcomes & Findings for Cali Sin Tos Aim 2 (NCT NCT06338462)
NCT ID: NCT06338462
Last Updated: 2025-10-09
Results Overview
Feasibility of the mHealth strategy was defined as the proportion of index persons with TB and household contacts at risk of TB who engaged with the chatbot, defined as responding to at least one message from the chatbot.
COMPLETED
NA
269 participants
within 14 days of invitation
2025-10-09
Participant Flow
No randomization in this trial. Single arm interventional study.
Participant milestones
| Measure |
Mobile Health and Oral Testing
to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design
Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes.
Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis
|
|---|---|
|
Overall Study
STARTED
|
269
|
|
Overall Study
COMPLETED
|
217
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Mobile Health and Oral Testing
to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design
Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes.
Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis
|
|---|---|
|
Overall Study
No intervention received due to inaccurate contact info, no WhatsApp, no internet, or no smartphone
|
52
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mobile Health and Oral Testing
n=269 Participants
to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design
Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes.
Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis
|
|---|---|
|
Age, Continuous
|
43 years
n=269 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=269 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=269 Participants
|
|
Region of Enrollment
Colombia
|
269 participants
n=269 Participants
|
|
Person living with HIV
|
17 Participants
n=191 Participants • Only measured among those with tuberculosis (n=191)
|
|
Pulmonary tuberculosis
|
166 Participants
n=191 Participants • Only among those with tuberculosis (n=191)
|
|
Person with tuberculosis
|
191 Participants
n=269 Participants
|
|
Contact of person with tuberculosis
|
78 Participants
n=269 Participants
|
PRIMARY outcome
Timeframe: within 14 days of invitationPopulation: Number of individuals who successfully received the chatbot. 52 did not receive the chatbot. We did not collect reasons why the chatbot was not received.
Feasibility of the mHealth strategy was defined as the proportion of index persons with TB and household contacts at risk of TB who engaged with the chatbot, defined as responding to at least one message from the chatbot.
Outcome measures
| Measure |
Mobile Health and Oral Testing
n=217 Participants
to adapt an automated conversation agent (Chatbot) and oral testing as a novel multi-component strategy for implementing TB contact investigation over three phases of participatory co-design
Chatbot: The chatbot is a WhatsApp-based, artificial-intelligence powered customer service agent adapted for TB outreach. The objective of the Chatbot is to facilitate information gathering, education, and support throughout TB contact evaluation, ensuring accessible assistance on-demand during and after contact tracing procedures. It operates in a secure data environment that includes end-to-end encryption and has been reviewed and approved by the data protection team within the information technology unit at the Cali Secretariat of Public Health (SoPH) for the study purposes.
Oral testing: Oral testing involves collection of a saliva sample or use of a nylon swab to collect material from the tongue and oral mucosa that is then tested with a molecular test for Mycobacterium tuberculosis
|
|---|---|
|
Implementation of the mHealth Strategy to Assess Feasibility.
|
112 Participants
|
PRIMARY outcome
Timeframe: within 7 days of screeningPopulation: Investigators were unable to pilot the oral testing strategy within contacts of persons with tuberculosis as the Ministry of Health cancelled the contract with the community health workers. Without the community health workers in place, this strategy was infeasible and will not be collected in the future.
Feasibility of the oral testing strategy defined as the proportion of eligible and enrolled contacts of the index person with TB with successful collection of an oral sample
Outcome measures
Outcome data not reported
Adverse Events
Mobile Health and Oral Testing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place